Neratinib

Neratinib (Nerlynx, Pierre Fabre Medicament) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HER2 (1).
Approved indications of Neratinib
Biomarker requirementRegimenSettingConditions
Breast cancer1
HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive
Monotherapy
Adj.
early
After adjuvant trastuzumab-based therapy completed less than one year ago
Full text of section 4.1 (therapeutic indications)

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

Label history

15 changes to the Nerlynx label since 2019, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes